Combined Use of Etomidate and Propofol in Painless Gastroscopy.
1 other identifier
interventional
2,450
1 country
6
Brief Summary
Gastroscopy, as a conventional examination for gastrointestinal tract disease, plays a very important role especially in early diagnosis and differential diagnosis of esophageal and gastric carcinoma. However, conventional gastroscopy is associated with several adverse effects (including throat discomfort, breath-holding, nausea, vomiting, laryngeal spasm and increased heart rate) due to which some patients are intolerant to this examination or even refuse the procedure due to fear of these effects. Recently, painless gastroscopy has been applied increasingly widely in outpatients to meet the increasing needs for comfortable medical care. Painless gastroscopy is commonly performed under general anesthesia without establishing an artificial airway. This is associated with an even higher anesthetic risk than general anesthesia in the operating room due to more basic patient monitoring and life-supporting equipment, only one anesthetist to perform anesthesia, fatigue in anesthesia, the requirement for a high turnover rate, as well as limited understanding of a patient's condition. Therefore, the availability of sedatives and analgesics which can provide rapid onset, sufficient sedation and analgesia, a short recovery time and less adverse effects are the premise of performing painless gastroscopy. Currently, combined intravenous anesthesia with fentanyl and propofol, commonly used in the clinic, is still associated with a long duration of action, hypotension in some patients and prolonged recovery. Etomidate has been increasingly utilized for in-clinic diagnosis and treatment for procedures such as painless coloscopy and early induced abortion due to its rapid onset, rapid metabolism and minimal impact on the circulatory and respiratory systems. However, no study on combined intravenous anesthesia with fentanyl and etomidate for painless gastroscopy had previously been reported. The main purpose of this study is to explore the efficacy and safety of combined intravenous anesthesia with fentanyl and etomidate for painless gastroscopy compared with the combination of fentanyl and propofol in middle aged and elderly patients, and to provide reliable evidence for the implementation and promotion of comfortable medical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2013
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2013
CompletedFirst Posted
Study publicly available on registry
July 31, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 16, 2013
July 1, 2013
4 months
July 25, 2013
December 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood pressure
Changes of blood pressure in each group will be recorded.
baseline to 10 min after the operation, an expected average of 20 minutes
Secondary Outcomes (3)
Heart rate
baseline to the end of the operation, an expected average of 30 minutes
Pulse Oxygen Saturation
baseline to the end of the operation, an expected average of 10 minutes
Respiratory rate
baseline to the end of the operation, an expected average of 10 minutes
Other Outcomes (6)
efficacy of anesthesia
From the time when propofol is given to discharge, an expected average of 30 minutes
Satisfaction
10 minutes after the operation
Recovery of anesthesia
10 min, 15 min and 15 min after the operation
- +3 more other outcomes
Study Arms (2)
Fentanyl & Propofol
ACTIVE COMPARATOR0.02 ml/kg(1 μg/kg) fentanyl is diluted to 10 ml with normal saline and infused within 1 min, 4 min advance. 0.5 mg/kg(0.025 ml/kg) propofol is infused within 15 to 20 s. And then, depending on the randomized result, 0.5 mg/kg is given every time until the patient falls asleep. During the operation, 0.5 mg/kg is given when it is needed.
fentanyl, propofol & etomidate
EXPERIMENTAL0.02 ml/kg(1 μg/kg) fentanyl is diluted to 10 ml with normal saline and infused within 1 min, 4 min advance. 0.5 mg/kg(0.025 ml/kg) propofol is infused within 15 to 20 s. And then, depending on the randomized result, 0.5 mg/kg etomidate is given every time until the patient falls asleep. During the operation, 0.5 mg/kg etomidate is given when it is needed.
Interventions
Eligibility Criteria
You may qualify if:
- Preparing to take gastroscopy;
- Age:between 45 to 75 years old (middle-aged group: 45\~59 years old; elderly group: 60\~75 years old; the percentage of middle-aged group and elderly group are 60% and 40%, respectively);
- BMI: between 18 to 25 kg/m2;
- ASA classification: grade Ⅰ\~Ⅱ.
You may not qualify if:
- Blood pressure before operation: \>180 mm Hg or \<90 mm Hg;
- ECG before operation: \<50 beats per min;
- HGB before operation: \<90 g/L;
- Infected with respiratory inflammation and not cured within 2 weeks;
- Sever heart, brain, pulmonary, heptic, renal diseases or diabetes;
- History of difficult airway or abnormal recovery from anesthesia before or difficult airway is predicted to occur ;
- Obvious electrolyte disturbance such as hyperkalemia;
- Treated with immunosuppressants such as hormones for a long time or prior inhibition of the adrenal cortex;
- Allergic to emulsion or opioids;
- Concomitant other sedatives or analgesics (including injectable or oral administration of treatment related to Chinese Traditional Patent Medicines);
- Suspected abuse of narcotic analgesics or sedatives;
- Patients for whom it is difficult to cooperate or communicate because of abnormalities of neuromuscular system or mental disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Chaoyang Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, 100020, China
General Hospital of Chinese Air Force
Beijing, Beijing Municipality, 100036, China
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100853, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weidong Mi, Senior
General Hospital of Chinese People's Liberation Army
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2013
First Posted
July 31, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 16, 2013
Record last verified: 2013-07